JP2022147528A - Fusion-accelerating device and medical appliance set - Google Patents

Abstract

To provide a fusion accelerating device that prevents or restrains slippage in living organs or prevents dropping from living organs when disposed in an adhesion target in the living organs.SOLUTION: A fusion-accelerating device 100 according to the present invention comprises: a sheet-like body portion 10 that is disposed between living organs to be adhered and accelerates fusion of living tissues; and a displacement portion 40, which is hollow and compressible in a thickness direction and in which at least an inner side S1 in a face direction YZ of the body portion can be displaced inwardly more than before the compressive deformation when compressed in the thickness direction.SELECTED DRAWING: Figure 4

Description

The present invention relates to a fusion promoting device and medical instrument set.

2. Description of the Related Art Techniques for surgically joining living organs (for example, gastrointestinal anastomosis) are known in the medical field. It is known that it is important as a postoperative prognostic factor that there is no delay in union at the junction where the living organs are joined together when the above procedures are performed.

Various methods and medical instruments are used in procedures for joining biological organs. For example, biodegradable sutures are used to suture biological organs, and a mechanical anastomosis device that performs anastomosis using a stapler (see Patent Document 1). It has been proposed to use the In particular, when performing anastomosis using a mechanical anastomosis device, the risk of suture failure can be reduced because the bonding force between living organs at the joint can be increased compared to the method using suture thread. becomes possible.

Japanese Patent Publication No. 2007-505708

In the anastomosis device of Patent Document 1, a sheet-like member such as a support structure is sandwiched in order to prevent leakage, tearing, or the like at the joint site, thereby promoting fusion of the joint site. Devices that promote such fusion (hereinafter referred to as fusion-promoting devices) are typically relatively thin and soft. Therefore, there is a problem that the sheet-like adhesion promoting device is likely to be displaced from the position intended by the operator or to fall off when the device is sandwiched between the relevant parts of the living tissue.

Accordingly, the present invention has been made to solve the above-described problems, and is capable of preventing or suppressing displacement from a living organ or preventing falling-off from the living organ when placed on a joining target of the living organ. intended to

A fusion promoting device according to an aspect of the present invention includes a body portion and a displacement portion. The main body is arranged between living organs to be joined, promotes fusion of living tissues, and is formed in a sheet shape. The displacement portion is formed hollow and is compressible in the thickness direction, and at least the inner side of the main body portion in the surface direction can be displaced more inward than before compressive deformation as it is compressed in the thickness direction. is.

Further, according to one aspect of the present invention, the above-described adhesion promoting device is joined to one joined site and the other joined site, which are biological organs to be joined, and a first engagement is provided in which the fusion promoting device can be sandwiched. a medical device comprising an instrument and a second engagement instrument. The second engaging device engages with the first engaging device, and includes a shaft that can be inserted through the displacement portion of the fusion promoting device and can come into contact with the inner side displaced inward in the planar direction.

ADVANTAGE OF THE INVENTION According to the fusion promoting device and the medical instrument set according to one aspect of the present invention, when placed on a joint target in a living organ, it prevents or suppresses displacement from the living organ, and prevents falling off from the living organ. be able to.

1 is a schematic perspective view showing a medical instrument set according to a first embodiment of the present invention; FIG. 2 is a perspective view showing the tip of a first engaging instrument and a second engaging instrument that constitute the medical device according to FIG. 1; FIG. FIG. 10 is a perspective view showing a state in which the fusion promoting device is inserted through the shaft of the second engaging instrument that constitutes the medical device; FIG. 4 is a cross-sectional view along the thickness direction of the fusion promoting device, showing a state before the displacement portion of the fusion promoting device is compressed in the thickness direction. FIG. 5 is a cross-sectional view showing a state in which a displacement portion is compressed in the fusion promoting device shown in FIG. 4; FIG. 4 is a cross-sectional view showing a through-hole provided in the main body of the fusion promoting device; 4 is a flow chart showing each procedure of a treatment method using the medical instrument set. 1 is a flow chart showing the procedure of an embodiment of a treatment method (colonic anastomosis). It is a figure explaining large intestine anastomosis using a medical device. It is a figure explaining large intestine anastomosis using a medical device. It is a figure explaining large intestine anastomosis using a medical device. FIG. 10 is a diagram showing a modified example of a holding part that constitutes the healing promoting device; FIG. 10 is a diagram showing a modified example of the holding portion that constitutes the fusion promoting device, and showing a state before compressing the displacement portion. FIG. 14 is a view showing a state in which the displacement portion is compressed in the fusion promoting device shown in FIG. 13; FIG. 10 is a diagram showing a state before compressing the displacement portion of the fusion promoting device according to the second embodiment. FIG. 10 is a diagram showing a state in which the displacement portion is compressed in the fusion promoting device according to the second embodiment; FIG. 10 is a plan view of the fusion promoting device according to the second embodiment, showing an operation of compressing the displacement portion in the thickness direction. FIG. 10 is a diagram showing a modification of the displacement portion in the fusion promoting device of the first embodiment;

EMBODIMENT OF THE INVENTION Hereinafter, the form for implementing this invention is demonstrated in detail, referring drawings. The embodiment shown here is an example for embodying the technical idea of the present invention, and does not limit the present invention. In addition, other practicable modes, embodiments, operation techniques, etc. that can be conceived by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are described in the scope of claims. included within the scope of the claimed invention and its equivalents.

Furthermore, the drawings attached to this specification may be represented schematically by appropriately changing the scale, length-to-width ratio, shape, etc. from the actual thing for the convenience of illustration and ease of understanding. and does not limit the interpretation of the present invention.

In the following description, ordinal numbers such as "first" and "second" will be used, but unless otherwise specified, they are used for convenience and do not prescribe any particular order.

Note that the coordinate system is shown in the drawings below. The X of the orthogonal coordinate system is along the axial direction or thickness direction of the main body 10 that constitutes the fusion promoting device 100, and is referred to as the axial direction X. Y and Z are planes that intersect the axial direction X and are referred to as planar directions YZ.

The r of the cylindrical coordinate system is a direction extending radially or radially from the center of the body portion 10 of the fusion promoting device 100 along the planar direction YZ, and is referred to as the radial direction r. θ is along the circumferential direction or angular direction of the main body 10 or the like in the plane direction YZ intersecting the axial direction X of the main body 10 or the like, and is referred to as the circumferential direction θ.

<First Embodiment>
FIG. 1 shows a medical instrument set 1 according to a first embodiment of the present invention. FIG. 2 is a diagram showing the distal end portion of the first engagement tool 210 and the second engagement tool 270 that constitute the medical device 200 that constitutes the medical instrument set 1. FIG. FIG. 3 is a diagram showing a state in which the shaft 310 of the second engagement device 270 is inserted through the hole 30 of the fusion promoting device 100. As shown in FIG. 4 and 5 are diagrams showing before and after compression of the displacement portion 40 constituting the fusion promoting device 100. FIG.

FIG. 6 is a diagram showing the through-hole 11 of the fusion promoting device 100. FIG. 7 to 11 are diagrams for explaining the anastomosis of the gastrointestinal tract, taking the large intestine as an example, using the fusion promoting device 100 that constitutes the medical instrument set 1. FIG.

The medical instrument set 1, as outlined with reference to FIG. 1, has a fusion promoting device 100 and a medical device 200 used together with the fusion promoting device 100 during anastomosis.

As shown in FIGS. 7 to 11, the fusion promoting device 100 can be applied to procedures for joining predetermined living organs (for example, gastrointestinal anastomosis). As will be described later, in the description of this specification, colon anastomosis will be described as an example of a procedure using the fusion promoting device 100, but the site where the fusion promoting device according to the present invention can be used is not limited to the large intestine.

The medical instrument set 1 is used to join a first site to be joined such as the large intestine and a second site to be joined using the medical device 200 . Before explaining the medical instrument set 1, the medical device 200 will be explained.

<Medical devices>
The medical device 200 joins one to-be-joined site (first to-be-joined site), which is a living organ in living tissue, and the other to-be-joined site (second to-be-joined site) facing the first to-be-joined site. The medical device 200 comprises a first engaging device 210 and a second engaging device 270 capable of sandwiching the fusion promoting device 100 via the first site to be joined and the second site to be joined.

The first engaging instrument 210 is arranged on one side of the fusion promoting device 100 when the fusion promoting device 100 is anastomosed to the living tissue as shown in FIG. 10 and the like. The first engaging tool 210 is configured to be able to contact the first joined portion.

The second engaging device 270 is arranged on the side opposite to the first engaging device 210 with respect to the union promoting device 100 during anastomosis, and is configured to be able to abut on the second site to be joined. Details will be described later. First engagement device 210 may be referred to as a trocar and second engagement device 270 may be referred to as an anvil. Details will be described below.

<First engagement device>
The first engaging device 210 includes an elongated member 220, a positioning portion 230, a releasing portion 240, a punching portion 250, and an operating portion 260, as shown in FIGS.

The elongated member 220 corresponds to the main body of the first engaging device 210 . As shown in FIG. 2 , the long member 220 has a space S at its longitudinal end in which the shaft of the positioning portion 230 can move forward and backward. In this specification, the axial direction X is the direction in which the distal end portion of the long member 220 extends linearly. The elongated member 220 has a hollow circular cross-section that intersects with the axial direction X. As shown in FIG.

In this embodiment, the long member 220 extends linearly in the longitudinal direction and has a bent portion. good too.

The positioning part 230 has an elongated shaft. As shown in FIG. 2, the shaft of the positioning part 230 is configured so as to move forward and backward relative to the space S at the longitudinal end of the long member 220 . The positioning part 230 is configured to be insertable into the hole 30 formed by the inner reinforcing part 21 of the fusion promoting device 100 and the shaft 310 of the second engaging instrument 270 described later.

The releasing part 240 is configured to release a plurality of staples (corresponding to anastomosis members) for joining the first site to be joined and the second site to be joined. The ejection portion 240 is formed in a substantially disk shape on the distal end side of the elongated member 220 in the longitudinal direction. The ejecting portion 240 is configured by providing a plurality of staple ejecting points along the circumferential direction θ at the distal end of the long member 220 .

The punching part 250 is arranged radially inward of the discharge part 240 at the distal end of the long member 220, and is configured to punch radially inwards of the first and second parts to be joined. there is As shown in FIG. 2, the punching part 250 is configured to have an annular blade that punches out the first and second parts to be joined radially inward of the discharge part 240 in the r direction. The shape of the punched portion 250 can be a perfect circle when viewed in plan from the longitudinal direction, but the shape of the punched portion 250 may be an ellipse or the like as long as it punches out a portion that is not necessary for promoting healing.

The operation part 260 is configured to be able to operate the positioning part 230 , the ejection part 240 and the punching part 250 . The operating section 260 includes a rotating section 261 and a handle 262 as shown in FIG.

The rotating portion 261 is provided at the proximal end portion (base end side) of the elongated member 220 in the longitudinal direction. The rotating portion 261 is configured to be rotatable with respect to the elongated member 220 with the longitudinal direction of the base end side of the elongated member 220 as a rotation axis. The rotating portion 261 rotates the elongated member 220 in a state where the second engaging device 270 is engaged with the first engaging device 210 , thereby rotating the first engaging device 210 and the second engaging device 270 . can be moved relatively close to each other.

The handle 262 is configured to be grippable by the user together with the base end (base end side) of the elongated member 220 . Handle 262 is rotatably connected to elongated member 220 by pivot 263 . The handle 262 rotates around the rotation axis 263 and relatively approaches the elongated member 220 when gripped by the user. Thereby, the staple is discharged from the discharging part 240 and the annular blade of the punching part 250 can be projected from the tip of the long member 220 .

<Second engagement device>
The second engaging device 270 is configured to be able to sandwich the healing promoting device 100 together with the first engaging device 210 via the first site to be joined and the second site to be joined. The second engagement device 270 includes a head 280, an abutment portion 290, and a shaft 310, as shown in FIG.

The head 280 is arranged particularly adjacent to the distal end side of the elongate member 220 of the first engaging device 210 when the first engaging device 210 and the second engaging device 270 are engaged. 2 and 3, the head 280 has a cross-sectional shape that is the same as or similar to the circular shape of the long member 220. As shown in FIGS.

The abutting portion 290 is configured to abut against a plurality of staples ejected from the ejecting portion 240 . The contact portion 290 is provided on the side of the first engaging device 210 in the axial direction X (thickness direction) of the head 280 . The abutting portion 290 is configured to abut against a plurality of staples ejected from the ejecting portion 240 . The staple ejected from the ejecting portion 240 abuts at the abutment portion 290 and deforms to join the first to-be-joined portion and the second to-be-joined portion.

The shaft 310 is configured to be able to pass through a hole 30 and a displacement portion 40 of the fusion promoting device 100, which will be described later. The shaft 310 includes a first shaft 311 and a second shaft 312 connected to the first shaft 311, as shown in FIG. The second shaft 312 is provided closer to the head 280 than the first shaft 311 is. The first shaft 311 is configured coaxially with the second shaft 312, and the cross section of the first shaft 311 and the second shaft 312 that intersects the axial direction X has a hollow circular shape.

The second shaft 312 is configured to have a smaller outer diameter than the first shaft 311 in this embodiment. The first shaft 311 is configured to be engageable with the shaft of the positioning portion 230, so that the first engaging device 210 and the second engaging device 270 can be engaged. The first shaft 311 and the second shaft 312 are configured to elongate in the axial direction X from the head 280 toward the first engaging device 210 .

A space is provided in the shaft 310 to accommodate the shaft of the positioning portion 230 of the first engaging device 210 . The shaft 310 is configured to mate with the shaft of the positioning portion 230 , thereby enabling alignment of the first engagement device 210 and the second engagement device 270 .

<Union promotion device>
The healing promoting device 100 includes a body portion 10, a reinforcing portion 20, a hole portion 30, a displacement portion 40, and a holding portion 50, as shown in FIG.

<Body part>
The main body 10 is arranged between living organs to be joined, and promotes fusion of living tissues. The body portion 10 is configured in a sheet shape as shown in FIG. 4 and the like.

As shown in FIG. 3, the main body 10 is formed in a circular shape as an example, and as shown in FIG. Provide multiple. As an example, the size of the through-hole 11 of the main body 10 is preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, still more preferably 0.6 to 1.5 mm. The body portion 10 can be configured such that the ratio of the dimension D of the through holes 11 to the pitch P is 0.25 or more and less than 40.

The thickness of the body portion 10 (the dimension T shown in FIG. 6) is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm.

The main body 10 can be made of biodegradable material. There are no particular restrictions on the constituent material of the main body 10, and examples include biodegradable resins.

Specifically, (1) selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose Polymer; (2) a copolymer composed of one or more monomers constituting the above (1);

That is, the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins and cellulose. It preferably contains at least one biodegradable resin selected from the group consisting of polymers and copolymers composed of one or more monomers constituting the polymer.

<Reinforcement part>
The reinforcement part 20 is provided to suppress twisting, displacement, breakage, etc. of the fusion promoting device 100 when the device 100 is placed between the first site to be bonded and the second site to be bonded by the medical device 200. be provided. The reinforcing portion 20 includes an inner reinforcing portion 21 and an outer reinforcing portion 22 as shown in FIG. The inner reinforcing portion 21 is formed along the inner peripheral edge of the hollow circular body portion 10 , and the outer reinforcing portion 22 is formed along the outer peripheral edge of the hollow circular body portion 10 .

The inner reinforcing portion 21 and the outer reinforcing portion 22 are formed in a shape in which the through hole 11 is not provided in the main body portion 10 in this embodiment. However, the specific shape of the reinforcing portion 20 is not limited to the above, and the position may not be the inner peripheral edge or the outer peripheral edge, as long as the fusion promoting device 100 can be prevented or prevented from twisting or slipping and the strength can be improved.

<Hole>
The hole portion 30 is configured to be spaced apart from the outer peripheral edge portion of the main body portion 10 in the plane direction YZ of the main body portion 10 . The hole 30 is configured so that the shaft 310 of the medical device 200 can be inserted therethrough. The hole portion 30 is configured in a substantially circular shape when viewed from the axial direction X in this embodiment. However, the specific shape of the hole is not limited to a circular shape, as long as the body can promote the fusion of living tissue.

<Displacement part>
The displacement portion 40 is hollow as shown in FIG. 3, and configured to be compressible in the thickness direction as shown in FIGS. The displacement portion 40 is configured such that at least the inner side S1 in the plane direction YZ of the body portion 10 can be displaced more inwardly in the radial direction r than before compressive deformation as it is compressed in the thickness direction. In the present embodiment, the displacement portion 40 is provided at a position different from that of the main body portion 10 in the thickness direction of the main body portion 10. More specifically, the displacement portion 40 is arranged adjacent to the main body portion 10 in the thickness direction of the main body portion 10. there is

The displacement part 40 comprises a folding point 41 which is compressible in the thickness direction and which has an inner side S1. In this embodiment, the folding portion 41 has an uneven portion formed by connecting a plurality of annular convex portions. The concave-convex portion of the folding portion 41 is configured such that the inner side S1 of the concave-convex shape is displaced more inwardly in the plane direction YZ than before deformation by being compressed in the thickness direction. The uneven portion of the folding portion 41 has a constant thickness in this embodiment. A slit (break) may be provided at the folding portion.

The degree of compression in the thickness direction of the displacement portion 40 is not particularly limited as long as the inner side S1 can contact the shaft 310 in the compressed state. can be to some extent. It is preferable that the displacement portion 40 has a large number of irregularities at the folded portion 41, and the height of the folded portion 41 in the thickness direction is preferably high in that the inner side S1 can be easily displaced inward in the radial direction r. Further, the shape of the corners of the folding portion may be sharp or rounded. The displacement portion 40 has the same outer shape regardless of the position in the thickness direction.

Further, the displacement portion 40 is provided with a bore 42 so that the shaft 310 of the second engaging device 270 can be inserted therethrough, as shown in FIG. 4 and the like.

The material of the displacement portion 40 is not particularly limited as long as the inner side S1 contacts the shaft 310 when compressed and the fusion promoting device 100 can be fixed to the shaft 310 . Examples of the material of the displacement portion 40 include at least one of resin, cloth and wire, spring, shape memory resin, and the like. When the displacement portion 40 contains a shape memory resin, it is preferable that the displacement portion 40 is stored in a non-compressed state in the thickness direction. Moreover, although the displacement portion 40 is configured separately from the main body portion 10 in this embodiment, the main body portion 10 and the displacement portion 40 may be configured integrally.

<Holding portion 50>
The holding portion 50 holds a state in which the inner side S1 is displaced inward in the planar direction YZ. The holding portion 50 is provided outside the displacement portion 40 in the plane direction YZ in this embodiment. The holding portion 50 includes a first engaging portion 51 and a second engaging portion 52 as shown in FIGS. 4 and 5 .

The first engaging portion 51 is configured to be engageable with the second engaging portion 52, and in this embodiment, the hook is formed on the side of the top portion opposite to the root portion where the main body portion 10 is located in the uneven side surface shape. It is configured to provide such a shape. However, if the inner side S1 can be displaced more inwardly in the surface direction YZ than before deformation, the position where the first engaging portion 51 is provided is not limited to the top, and the position where the first engaging portion 51 is provided is not limited to the thickness. A portion other than the end portion in the direction may be used.

The second engaging portion 52 engages the first engaging portion 51 associated with the hook so that the uneven side surface shape can be maintained in an axially compressed state. The second engaging portion 52 is configured to have a hole-like shape in the body portion 10 in this embodiment. The first engaging portion 51 and the second engaging portion 52 can be engaged as shown in FIG. 5 by moving the first engaging portion 51 and the second engaging portion 52 so that they approach each other in the thickness direction.

The material of the displacement portion 40 is not particularly limited as long as the inner side S1 can be displaced radially inward from the state before deformation. The material of the displacement part 40 is polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene-terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyurethane. Thermoplastic resins such as polyamides, polyamide elastomers, polystyrene elastomers, silicone rubbers, latex rubbers, and the like can be used.

A method for manufacturing the main body 10 is not particularly limited, but for example, a method of manufacturing fibers made of the biodegradable resin described above and manufacturing a mesh-shaped sheet using the fibers can be mentioned. A method for producing fibers made of a biodegradable resin is not particularly limited, but examples thereof include an electrospinning method (electrospinning method/electrostatic spinning method) and a meltblowing method. For the main body 10, only one of the above methods may be selected and used, or two or more methods may be selected and appropriately combined. As still another example of the method for manufacturing the main body 10, the biodegradable sheet according to the present invention can be obtained by spinning fibers made of the above-described biodegradable resin according to a conventional method and knitting the obtained fibers into a mesh. , a method of producing the biodegradable sheet by compressing the fibers, and a method of producing the biodegradable sheet by entangling the fibers without weaving.

The main body 10 causes a bioreaction by using a constituent material such as a biodegradable resin that constitutes the main body 10 . By this action, the main body 10 induces the expression of biological components such as fibrin. The biocomponents induced in this manner penetrate through the through holes 11 of the main body 10 and accumulate, thereby promoting the fusion. Therefore, by arranging the body part 10 of the fusion promoting device 100 between the living organs to be bonded, the fusion is promoted by the above mechanism.

<Treatment method>
Next, a treatment method using the healing promoting device 100 will be described. FIG. 7 is a flow chart showing each procedure of the treatment method using the fusion promoting device.

In the treatment method, as shown in FIG. 7, a sheet-like main body portion 10 that promotes fusion of living tissue is placed between a first site to be bonded on one side and a second site to be bonded on the other side, which are objects to be bonded with living organs. Placing (S11) a fusion promoting device 100 comprising: In the treatment method, one first to-be-joined site and the other second to-be-joined site are placed in a state in which at least a part of the main body portion 10 of the healing promoting device 100 is placed between the one first to-be-joined site and the other second to-be-joined site. It includes joining the second joined site (S12).

The living organ to be joined by the treatment method and the site to be joined in the living organ are not particularly limited and can be arbitrarily selected. However, in the following description, colon anastomosis will be taken as an example. Further, in each technique described below, detailed descriptions of known technique procedures and known joining devices will be omitted as appropriate.

Hereinafter, in the description of this specification, "arranging the adhesion-promoting device between living organs (hereinafter referred to as the above description)" means that the adhesion-promoting device is in direct or indirect contact with the living organ. It can mean placed.

Also, the above description can mean that the fusion promoting device is arranged with a spatial gap formed between it and the living organ. In addition, the above description also states that the adhesion promoting device is placed in both states (for example, the device is placed in contact with one living organ and not in contact with the other living organ). be done).

In addition, in the description of this specification, the term "periphery" does not define a strict range (region). means

In addition, the order of the procedure described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. In addition, in the description of this specification, "bringing relatively close together" means both bringing two or more objects to be brought closer together and bringing only one of them closer to the other.

FIG. 8 is a flow chart showing the procedure of an embodiment of the treatment method (colonic anastomosis). 9 to 11 are diagrams for explaining colon anastomosis.

In the treatment method according to this embodiment, the living organ to be joined is the large intestine that has been cut along with resection of the cancer tumor. Specifically, the living organs to be joined are the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine. In the following description, the procedure for joining the oral periphery (one site to be joined) of the mouth side A1 of the cut large intestine and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other site to be joined) will be described. explain.

As shown in FIG. 8, the treatment method according to the present embodiment includes disposing the fusion promoting device 100 between the mouth of the large intestine and the intestinal wall of the large intestine (S101), Including bringing the walls relatively close together (S102). The treatment method is to sandwich the main body 10 of the adhesion-promoting device 100 between the periphery of the mouth of the large intestine and the wall of the large intestine (S103), and insert the device between the periphery of the mouth of the large intestine and the wall of the large intestine. It includes joining the main body part 10 of 100 in a sandwiched state (S104). Details will be described below.

First, the operator forms a hole-like portion called a port around the navel and inflates the patient's abdomen.

Next, the operator forms an incision (not shown) around the navel, takes out the affected part on the oral side A1 from the incision, and inserts the second engaging tool 270 of the medical device 200 into the oral side A1 of the large intestine. insert The operator inserts the head 280 of the second engaging instrument 270 into the mouth side A1 of the large intestine, performs purse-string suture with the shaft 310 protruded, and forms the sutured portion A11. The outer surface of the sewn portion A11 has a shape that partially protrudes to the convex side as a result of the sewing (see FIG. 9).

Next, the operator places the fusion promoting device 100 on the living tissue on the oral side A1 of the large intestine (S101). Next, as shown in FIG. 9, the operator pushes the displaceable portion 40 of the fusion promoting device 100 in the thickness direction using fingers, bringing the top portion of the displaceable portion 40 closer to the base, thereby engaging the holding portion 50 in the first engagement. The hook associated with the portion 51 is operated to engage with the hole associated with the second engaging portion 52 .

As a result, the inner side S1 of the displacement portion 40 is displaced inward in the plane direction YZ, and the inner side S1 of the displacement portion 40 comes into contact with the shaft 310 of the second engaging device 270 as shown in FIG. As a result, the fusion promoting device 100 including the displacement portion 40 is fixed to the shaft 310 .

Next, the operator puts the living tissue on the mouth side A1 of the large intestine where the fusion promoting device 100 is placed into the body through the incision.

Next, the operator places the first engaging instrument 210 of the medical device 200 on the anal side A2 of the large intestine. As the first engaging device 210 is placed (inserted) on the anal side A2 of the large intestine, a through hole A21 is formed on the anal side A2 of the large intestine. The timing of forming the through hole A21 is not particularly limited as long as it is after the first engaging device 210 is arranged.

Next, the operator engages the shaft of the positioning part 230 and the shaft 310 of the second engaging device 270 at a spaced apart position while maintaining the state of holding the main body 10 against the mouth side A1 of the large intestine. Let Then, the rotating part 261 is rotated to bring the first engaging device 210 and the second engaging device 270 closer to each other as shown in FIGS. 9 and 10 . As a result, the periphery of the mouth of the large intestine and the intestinal wall of the large intestine relatively approach each other (S102).

Next, between the first engaging device 210 and the second engaging device 270, the operator moves around the mouth on the mouth side A1 of the large intestine, the main body 10 of the fusion promoting device 100, and the anus side A2 of the large intestine. The periphery of the through hole A21 formed in the intestinal wall is sandwiched (S103).

The operator rotates the handle 262 of the operating portion 260 of the medical device 200 around the rotating shaft 263 to protrude the annular blade of the punching portion 250 . Then, a portion of the mouth side A1 of the large intestine sandwiched between the first engaging device 210 and the second engaging device 270, a radially inner side of the main body 10, and a portion of the anal side A2 of the large intestine are excised. Then, the periphery of the excised portion is joined with staples (not shown) (S104).

Next, as shown in FIG. 11, the operator takes the medical device 200 out of the body, for example, from the anal side A2 of the large intestine through the anus. At this time, the region configured inside the outer diameter d of the punched portion 250 of the first engaging instrument 210 is taken out of the living body together with the medical device 200 . As a result, portions of the fusion promoting device 100, such as the displacement portion 40, which are located inside the punched portion 250 in the radial direction r are removed without remaining in the body.

The main body 10 of the fusion promoting device 100 is sandwiched and indwelled between the living organs to be joined, thereby promoting the fusion of the living organs to be joined through the through holes A21 of the main body 10.

According to such a treatment method, a joining procedure (for example, gastrointestinal anastomosis) is performed by a simple method of sandwiching the sheet-like main body 10 between the first site to be joined and the second site to be joined. It is possible to reduce the risk of subsequent suture failure and the like.

As described above, the fusion promoting device 100 according to this embodiment includes the body portion 10 and the displacement portion 40 . The main body 10 is arranged between living organs to be joined, and is configured in a sheet shape to promote the fusion of living tissues. The displacement portion 40 is hollow and configured to be compressible in the thickness direction. The displacement portion 40 is configured such that the inner side S1 of the body portion 10 in the plane direction YZ can be displaced more inwardly than before compressive deformation as it is compressed in the thickness direction.

Further, the medical instrument set 1 according to this embodiment includes the above-described healing promoting device 100 and medical device 200 . The medical device 200 joins a first site to be joined and a second site to be joined, which are biological organs to be joined, and includes a first engaging device 210 capable of sandwiching the fusion promoting device 100, and a second engaging device. 270 and. The second engaging device 270 engages with the first engaging device 210, can be inserted through the hole portion 30 and the displacement portion 40 of the fusion promoting device 100, and contacts the inner side S1 displaced inward in the planar direction YZ. A contactable shaft 310 is provided.

With this configuration, the inner side S1 of the displacement portion 40 is displaced inward in a state in which the shaft 310 of the second engaging device 270 is inserted into the inner side of the fusion promoting device 100, and the inner side S1 of the fusion promoting device 100 is displaced. Device 100 can be secured to shaft 310 . As a result, during the procedure of joining the first site to be joined and the second site to be joined, the fusion promoting device 100 can be prevented or suppressed from being displaced from the living organ, or can be prevented from falling off from the living organ. can do.

In addition, since the inner side S1 of the displacement portion 40 is not displaced inward before deformation, the body portion 10 can be easily inserted into the shaft 310 . As a result, it is possible to prevent or suppress damage or breakage of the fusion promoting device 100 when inserting the device 100 through the shaft 310 or the like.

Further, the displacement portion 40 is arranged adjacent to the body portion 10 in the thickness direction of the body portion 10 . By configuring in this way, the fusion promoting device 100 can be brought into contact with the base of the shaft 310 such as the second shaft 312 and can be easily fixed to the shaft 310 .

Further, the displacement portion 40 is configured to be expandable and contractible in the thickness direction of the main body portion 10 and provided with a folding portion 41 provided with an inner side S1. With this configuration, the inner side S1 of the displacement portion 40 can be brought into contact with the shaft 310 to fix the fusion promoting device 100 to the shaft 310 .

Further, the folding portion 41 of the displacement portion 40 includes an uneven portion formed by connecting a plurality of annular convex portions. With this configuration, the fusion promoting device 100 can be fixed to the shaft 310 by compressing the folded portion 41 in the thickness direction to bring the inner side S1 into contact with the shaft 310 .

The fusion promoting device 100 also includes a holding portion 50 that maintains a state where the inner side S1 of the displacement portion 40 is displaced inward in the planar direction YZ, and is provided further outward than the displacement portion 40 in the planar direction YZ. By configuring in this way, the displacement portion 40 is kept compressed in the thickness direction, and it is possible to prevent the fixation of the fusion promoting device 100 to the shaft 310 from being released during the procedure.

The healing device 100 also includes a hole 30 formed apart from the outer peripheral edge of the main body 10 in the plane direction YZ of the main body 10 . With this configuration, the shaft 310 of the medical device 200 can be easily inserted into the fusion promoting device 100 when fixing the device 100 to the shaft 310 of the medical device 200 .

<Modification 1>
12A and 12B are diagrams illustrating the holding portion 50b of the fusion promoting device 100a according to Modification 2. FIG. In the first embodiment, it was explained that the holding portion 50 includes the first engaging portion 51 including the hook shape and the second engaging portion 52 including the hole portion that engages with the hook shape of the first engaging portion 51 .

However, if the holding portion can fix the fusion promoting device to the shaft 310 by abutting the inside of the deformable portion on the shaft, the holding portion can also be configured as follows.

Note that the main body 10, the reinforcing portion 20, and the hole portion 30, which constitute the healing promoting device 100a in this modified example, are the same as those in the first embodiment, so the description thereof is omitted.

In this embodiment, the holding portion 50a is configured to include a first partition portion 51a, a second partition portion 52a, and a valve body 53a, as shown in FIG.

The first partition portion 51a is configured to be provided at the top portion of the folded shape separated from the main body portion 10 in the thickness direction. The first partition 51a can be configured such that the inner edge contacts the shaft 310 when the shaft 310 of the second engaging device 270 is inserted therethrough.

The second partition portion 52a is provided near the main body portion 10 in the thickness direction. The second partition portion 52 a can be configured such that the hole portion 30 is smaller than the outer shape of the contact portion 290 of the second engaging device 270 . By providing the holding portion 50a with the first partition portion 51a and the second partition portion 52a, the lumen 42a of the displacement portion 40a can be made a closed space when the shaft 310 is inserted through the fusion promoting device 100a.

The valve body 53a is configured to provide an opening that communicates the lumen 42a with the outside, and the lumen 42a is closed by performing a closing operation with the shaft 310 inserted into the hole 30 of the fusion promoting device 100a. It is configured to be a closed space. The valve body 53a is provided at a position spaced apart in the radial direction r from the shaft 310 in the assembled state at the folded portion 41 of the displacement portion 40. As shown in FIG. By providing the valve body 53a, the compressed state can be maintained when the displacement portion 40a is compressed in the thickness direction. The valve body 53a is not particularly limited as long as it can release air that may exist in the lumen 42a to the outside when the valve body 53a is compressed in the thickness direction, and can hold the lumen 42a in a closed space when the valve body is closed. may include a one-way valve as an example.

The displacement portion 40a is different from the first embodiment in the shape of the lumen 42a formed by the folding portion 41, the first partition portion 51a, and the second partition portion 52a. Since it is the same, the explanation is omitted.

Moreover, the treatment method using the device 100 for promoting healing according to the present modification differs in the operation of the holding portion 50a when bringing the inner side S1 of the folded portion 41 of the displacement portion 40a into contact with the shaft 310. FIG.

After compressing the displacement portion 40a with the hole portion 30 of the fusion promoting device 100a inserted into the shaft 310, the operator closes the valve body 53a to maintain the compressed state of the displacement portion 40a. Others are the same as those of the first embodiment, so description thereof will be omitted.

As described above, in the present modified example, the holding portion 50a has the first partition 51a on the top side of the folding portion 41, and the second partition 52a on the root side to compress the folding portion 41. At this time, the displacement portion 40a is held in a compressed state by the valve body 53a of the holding portion 50a. With this configuration as well, the inner side S1 of the displacement portion 40a can be kept in contact with the shaft 310. As shown in FIG.

<Modification 2>
13 and 14 are diagrams showing a holding portion 50b that constitutes a healing promoting device 100b according to Modification 2. FIG. In the first embodiment, it has been described that the holding portion 50 includes the first engaging portion 51 having a hook shape and the second engaging portion 52 including a hole. However, if the state where the inner side S1 of the displacement portion 40 is in contact with the shaft 310 can be maintained, the specific configuration of the holding portion can be configured as follows.

Note that the body portion 10, the reinforcing portion 20, the hole portion 30, and the displacement portion 40, which constitute the healing promoting device 100b, are the same as those in the first embodiment, and thus description thereof is omitted.

The holding portion 50b includes a first engaging portion 51b and a second engaging portion 52b, as shown in FIGS. The first engaging portion 51b is configured to be engageable with the second engaging portion 52b, and is configured to include a thread-like member forming a hole in this embodiment. In the present embodiment, the second engaging portion 52b is configured to have a hook-like shape on the body portion 10 so as to maintain a state in which the hole portion of the first engaging portion 51b is hooked.

The treatment method using the medical instrument set according to this modified example differs from the first embodiment in the method of engaging the first engaging portion 51b of the holding portion 50b with the second engaging portion 52b.

After compressing the displacement portion 40 with the shaft 310 inserted through the hole 30 of the fusion promoting device 100b, the operator presses the hole formed by the filament member associated with the first engaging portion 51b of the holding portion 50b. The second engaging portion 52b is engaged with the hook shape. As a result, the displacement portion 40 is maintained in a state of being compressed in the thickness direction as shown in FIG. Others are the same as those of the first embodiment, so description thereof will be omitted.

As described above, in Modification 2, the hole formed by the thread member in the first engaging portion 51b is configured to engage with the hook shape of the second engaging portion 52b. With this configuration, the inner side S<b>1 of the displacement portion 40 can also be kept in contact with the shaft 310 .

<Second embodiment>
FIG. 15 is a diagram showing a fusion promoting device 100c according to the second embodiment. In the first embodiment, it was explained that the displacement portion 40 of the fusion promoting device 100 has the folding portion 41 including the uneven portion formed by connecting a plurality of annular convex portions. However, if the displacement portion can contact the shaft 310 of the second engagement device 270 when compressed in the thickness direction and fix the fusion promoting device to the shaft 310, the following configuration is also possible.

Note that the body portion 10, the reinforcing portion 20, and the hole portion 30, which constitute the healing promoting device 100c, are the same as those in the first embodiment, so description thereof will be omitted.

The displacement portion 40c is configured to have a folding portion 41c as shown in FIG. 15, and the folding portion 41c is configured to include a spirally formed uneven portion. The folding portion 41c of the displacement portion 40c is not only compressed in the thickness direction, but also compressed in the thickness direction by rotating the thickness direction (axial direction X) as the axis of rotation, so that the inner side S2 becomes the diameter. It is configured to be displaced inward in the direction r.

The shape of the lumen 42c forming the displacement portion 40c is different from the shape of the lumen 42 according to the first embodiment because the shape of the folding portion 41c is different from the shape of the folding portion 41 according to the first embodiment. However, since the bore 42c is the same as in the first embodiment in that the shaft 310 of the second engaging device 270 is inserted therethrough, detailed description thereof will be omitted.

The holding portion 50c includes a first engaging portion 51c and a second engaging portion 52c, as shown in FIG. In this embodiment, the first engaging portion 51c is configured to have a hook shape similar to that of the holding portion 50 of the first embodiment.

In this embodiment, the second engaging portion 52c is configured to include a hole that can be engaged with the hook shape of the first engaging portion 51c, as in the first embodiment. As shown in FIG. 17, the displacement portion 40c is compressed in the thickness direction while being twisted or twisted in the circumferential direction .theta. Both can be engaged by aligning the positions in the direction θ.

The treatment method using the fusion promoting device 100c differs in fixing the fusion promoting device 100c to the shaft 310 by compressive deformation of the displacement portion 40c. When deforming the displacement portion 40c, the operator grasps the displacement portion 40c with fingers and pushes it in the thickness direction while rotating it in the circumferential direction θ as shown in FIG.

As a result, as shown in FIG. 16, the spiral shape of the folded portion 41c of the displacement portion 40c rotates in the circumferential direction θ, and the height in the thickness direction decreases, so that the inner side S2 is displaced inward in the radial direction r. and come into contact with the shaft 310 . The state in which the inner side S2 of the displacement portion 40c is in contact with the shaft 310 is maintained by the engagement between the first engaging portion 51c and the second engaging portion 52c of the holding portion 50c. Since other operations are the same as those in the first embodiment, description thereof is omitted.

As described above, in the present embodiment, the folding portion 41c of the displacement portion 40c is configured to include a spirally formed uneven portion. With this configuration, the fusion-promoting device 100c is also fixed to the shaft 310 to prevent or suppress the displacement of the fusion-promoting device 100c with respect to the living organ during a procedure, or to prevent the device from falling off from the living organ. can do. In addition, the fusion promoting device 100c can contribute to preventing twisting of a biological organ such as an intestinal tract by maintaining its rotated state.

The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. In the second embodiment, the holding portion 50c having the first engaging portion 51c including the hook shape and the second engaging portion 52c including the hole portion compresses the displacement portion 40c compressed in the thickness direction while rotating. I explained that the status is preserved.

However, if the inner side S2 of the displacement portion 40c can be maintained inwardly displaced in the radial direction r, the compressed state of the displacement portion 40c can be maintained using the holding portion 50a including the valve body 53a as in Modification 1. good too. Further, the compressed state of the displacement portion 40c may be held by using the holding portion 50b including the first engaging portion 51b including the filament member of Modification 2 and the second engaging portion 52b including the hook shape.

In addition to the configurations described in the first embodiment, modified example 1, and modified example 2, the holding portion may be configured to hold the compressed state of the displacement portion by hook and loop engagement such as hook-and-loop fastener. may

Further, in the modified example 1, it was explained that the valve body 53a constituting the holding portion 50a is provided in the displacement portion 40, but if the displacement portion can hold the compressed state, the valve body 53a constituting the holding portion can be attached to the shaft of the second engaging device. A body may be provided.

Further, in the first embodiment, modified example 1, modified example 2, etc., it has been described that the holding portion is configured as a separate component from the displacement portion 40 . However, if it is possible to maintain the compressed state of the displacement portion by the operation of the operator, the folded portion of the displacement portion can be kept in the compressed state by the physical properties of its own material without providing a holding portion separately from the displacement portion. may be configured.

Further, in the first embodiment, modified example 1, modified example 2, and the second embodiment, it was explained that the hole portion 30 is provided inside the body portion 10 of the healing promoting device in the radial direction r. However, other than the above, the holes of the fusion promoting device are not formed in the distribution stage of the product, and are configured to be formed only when the operator inserts the fusion promoting device into the shaft 310 during the procedure. good too.

18A and 18B are diagrams showing a modification of the displacement portion 40 of the fusion promoting device 100 according to FIG. In the first embodiment, it has been described that the displacement portion 40 has the same or little change in outer shape even if the dimension in the radial direction r changes the position in the axial direction X. However, the configuration of the deformable portion is not limited to this, as long as the inner side contacts the shaft 310 when the deformable portion is compressed and the fusion promoting device can be fixed to the shaft 310 .

In addition to the above, the displacement portion 40d is configured so that the dimension of the folding portion 41d provided with the inner side S3 increases as the displacement portion 40d approaches the root portion near the main body portion 10 from the top portion thereof, as shown in FIG. good too. By configuring in this way, the contact portion 290 of the second engaging device 270 can be more easily pressed. In addition, it can contribute to preventing the displacement portion 40d from being unintentionally compressed when the fusion promoting device 100d is inserted into the shaft 310 of the second engagement tool 270.

The shape of the lumen 42d forming the displacement portion 40d differs from that of the first embodiment because the shape of the folding portion 41d differs from that of the first embodiment. However, since it is the same as the first embodiment in that the shaft 310 of the second engaging tool 270 is inserted, detailed description thereof will be omitted. Further, the main body portion 10, the reinforcing portion 20, the hole portion 30, the holding portion 50, and the treatment method using the fusion promoting device 100d, which constitute the healing promoting device 100d, are the same as those in the first embodiment, so the description thereof will be omitted.

Also, the healing promoting device 100 does not have to include the reinforcing section 20 as long as it includes the main body section 10, the displacement section 40, and the like.

Further, second engagement instrument 270 of medical device 200 has been described as shaft 310 comprising first shaft 311 and second shaft 312 having different diameters. However, the shaft of the second engaging device is not limited to the above, and may be configured with a cylindrical shape or the like having a single diameter.

10 main body,
30 holes,
40, 40a, 40c, 40d displacement part,
41, 41d Folding part (uneven part formed by connecting a plurality of annular convex parts),
41c Folding part (helically formed uneven part),
50, 50a, 50b, 50c holding portion,
100, 100a, 100b, 100c, 100d adhesion promoting device;
200 medical devices;
210 first engagement device;
270 second engagement device;
310 shaft,
r radial direction,
S1, S2, S3 inside,
X-axis direction (thickness direction of main body),
YZ plane direction.

Claims (8)

a sheet-like main body that is placed between living organs to be joined and promotes fusion of living tissues;
It is formed hollow and is compressible in the thickness direction, and at least the inner side of the main body in the surface direction can be displaced more inward than before compressive deformation due to the compression in the thickness direction. A fusion promoting device comprising a displacement portion. The fusion promoting device according to claim 1, wherein the displacement portion is arranged adjacent to the body portion in the thickness direction of the body portion. The fusion promoting device according to claim 1 or 2, wherein the displacement portion is compressible in the thickness direction of the body portion and includes a folding portion provided with the inner side. 4. The healing promoting device according to claim 3, wherein the folding portion includes an uneven portion formed by connecting a plurality of annular convex portions. 4. The healing promoting device according to claim 3, wherein the folding portion includes a spirally formed uneven portion. 6. The holding portion further comprises a holding portion that holds a state in which the inner side of the displacement portion is displaced inward in the planar direction, and is provided further outward in the planar direction than the displacement portion. The device for promoting adhesion according to . The healing promoting device according to any one of claims 1 to 6, further comprising a hole formed apart from the outer peripheral edge of the main body in the surface direction of the main body. A fusion promoting device according to any one of claims 1 to 7;
A medical device comprising a first engaging device and a second engaging device that join one site to be joined and the other site to be joined, which are the living organs to be joined, and can sandwich the fusion promoting device. and
The second engaging device engages with the first engaging device, and has a shaft that can be inserted through the displacement portion of the fusion promoting device and can come into contact with the inner side displaced inward in the planar direction. A set of medical instruments to prepare.

Images